BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIX ANKER

    MDR report key: 843064 · Received October 13, 2006

    Report

    Report Number
    8031010-2006-00472
    Event Type
    Malfunction
    Date Received
    October 13, 2006
    Date of Event
    April 6, 2006
    Report Date
    September 15, 2006
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    ELR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS NO INDICATION THAT PATIENT INJURY OCCURRED, WITH CORRECTIVE ACTION CONSISTING OF REPLACING THE POST WITH A NEW ONE, THERE HAVE BEEN PREVIOUS REPORTS OF THIS MALFUNCTION THAT NECESSITATED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THE DEVICE WAS RETURNED FOR EVAL, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RADIX ANKER POST SEPARATED APPROX SIXTEEN MONTHS AFTER PLACEMENT. THE SEPARATED PIECE WAS RETRIEVED AND THE POST REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIX ANKER ELR ELR DENTSPLY MAILLEFER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR CULMAT LC| CULMAT AT